FDA device listing
Kubula External Drainage Catheter
FDA device listing 1949482836 · Sotera Health LLC
Key facts
| Proprietary names | Kubula External Drainage Catheter |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | JXG |
| Device names | JXG - Shunt, Central Nervous System And Components |
| Device class | Class II |
| Classification regulations (21 CFR) | 882.5550 |
| Review panels | Neurology |
| Registered establishments | Sterigenics SAS |
| Establishment registrations | 3007156625 |
| FEI numbers | 3008133910 |
| Establishment operations | Contract Sterilizer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database